National Biosafety Committee consists of the following members :-
|1||Secretary, Ministry of Climate Change||Chairman|
|2||Chairman, Pakistan Agriculture Research Council||Vice Chairman|
|3||Member (Science), Pakistan Atomic Energy Commission||Member|
|4||Representative, Government of Punjab||Member|
|5||Representative, Government of Balochistan||Member|
|6||Representative, Government of Sindh||Member|
|7||Representative, Government of KPK||Member|
|8||Representative, Environmental Protection Agency, Azad Jammu & Kashmir||Member|
|9||Representative, Gilgit Baltistan Secretariat, Forest Wildlife and Environment Department||Member|
|10||Representative, Ministry of National Food Security & Research||Member|
|11||Representative, Ministry of National Health Services, Regulation and Coordination||Member|
|12||Representative, Higher Education Commission||Member|
|13||Representative, Ministry of Science and Technology||Member|
|14||Representative, Ministry of Commerce & Textile Industry||Member|
|15||Representative, Federal Board of Revenue||Member|
|16||Representative, Ministry of Industries & Production||Member|
|17||Director General, Pakistan Environmental Protection Agency||Member/Secretary|
(2) The Director-General, Pakistan EPA, shall act as Secretary of the National Bio-safety Committee
(3) The Committee may co-opt any other member as deemed necessary for its functioning.
(4) The members of the Committee, other than ex-officio members, shall hold office for a term of three years extendable to another term of three years with the approval of the Chairperson
(5) The Committee shall frame its own rules and procedures.
(6) The Committee shall hold meetings as and when deemed necessary. provided that not less than four meetings shall be held in a year.
1. Functions of National Biosafety Committee._(1) The National Biosafety Committee shall i-form the following functions:
a) to establish standards and procedures for risk assessment and labeling of living modified organisms, substances or cells and products thereof.
b) to consider application(s) for import, export or commercial release of living modified organisms, and on the recommendations of Technical Advisory Committee allow release or reject applications after reviewing the risk assessment carried out in accordance with the Biosafety guidelines, the procedures established under sub-rule 5(a) and any other reliable information.
c) to ban or restrict import, export, sale, purchase or trading of any living modified organism causing or likely to cause risk to public health, safety or environment.
d) to develop linkages with foreign Biosafety committees and relevant agencies to ensure that genetic manipulation practices in Pakistan address international Biosafety concerns and observe universal codes of conduct.
e) to cooperate with other relevant national/provincial authorities overseeing the import and release of living organisms and formulate guidelines for the identification, inspection and regulation of transgenic species exotic organisms and others.
f) to restrain on the advice of Technical Advisory Committee any person, authority or institute involved with genetic manipulation experiments of potential hazards.
g) to facilitate exchange of technical expertise to various research institutions and regulatory agencies in setting up appropriate experimental conditions.
h) to Facilitate all levels of supervision of genetic manipulation work by assisting other regulatory bodies including institutional Biosafety Committees, in establishing pertinent codes disciplines and guidelines for the appraisal of Bio-hazards and the management of bio- safeguards.
i) to coordinate efforts of Institutional Biosafety Committees and inform and educate the public on Biosafety issues and on proposed national policies.
j) to ensure that laboratory, field work and commercial release of genetically modified organisms and their products conforms to the national Biosafety guidelines.
k) to prepare and provide to Institutional Biosafety Committees the various notifications and assessment forms. Biosafety guidelines, related documents and assorted signs for facilities.
l) to inform the various institutions engaged in genetic manipulation work about new developments in Biosafety so as to avoid exposure of laboratory personnel, the community or the environment to undue risks.
m) to coordinate efforts between pertinent government agencies and private organizations to maintain safety levels in biotechnological work and to prepare them for biological emergencies.
n) to certify high-level laboratories, plant glass houses and animal houses intended for use in high-risk work. Upon request by the institution, and at the earliest convenience, the National Biosafety Committee may inspect a facility and either issue certification, or recommend additional precautions, if elements of the facility are determined to be inadequate to support the types of risk-hazard companying work requiring such physical containment.
o) to inspect high-level laboratories and containment facilities on a regular basis. The National Biosafety Committee may inspect laboratories and facilities of containment level C2. P1-12. C2A, as specified in the bio safety guidelines, equivalent or higher at any time subsequent to certification without prior notice.
p) to inspect systems equipment and instruments governing ambient Biosafety levels in genetic manipulation laboratories.
q) to keep information of commercial significance confidential from public domain if so requested in writing by applicant, person or institution or organization.
r) to monitor the safety related aspects of on going research Projects and achievements involving genetically engineered organisms/hazardous substances or cells and products thereof.
2. Technical Advisory Committee:– (1) Technical Advisory Committee consists of the following members :
|1||Director General, Pakistan Environmental Protection Agency||Chairman|
|2||Director, National Institute of Bio Technology and Genetic Engineering, Faisalabad||Vice Chairman|
|3||Executive Director, Pakistan Medical Research Council (PMRC), Islamabad||Member|
|4||Member (Science), Pakistan Council of Industrial and Scientific Research (PCSIR), Islamabad||Member|
|5||Executive Director, National Institute of Health (NIH), Islamabad||Member|
|6||Director, Centre for Molecular Genetics, University of Karachi||Member|
|7||Representative, Centre for Applied and Molecular Biology, Lahore||Member|
|8||Relevant Technical Expert (Plant Sciences), Pakistan Agriculture Research Council (PARC), Islamabad||Member|
|9||Relevant Technical Expert (Animal Sciences), Pakistan Agriculture Research Council (PARC), Islamabad||Member|
|10||Technical Expert, Environmental Protection Agency Punjab||Member|
|11||Technical Expert, Environmental Protection Agency Sindh||Member|
|12||Technical Expert, Environmental Protection Agency Khyber Pakhtun Khawa||Member|
|13||Technical Expert Environment, Sports & Youth Affairs Department, Balochistan||Member|
|14||Technical Expert, Environmental Protection Agency Azad Jammu & Kashmir||Member|
|15||Technical Expert, Environmental Protection Agency Gilgit Baltistan||Member|
|16||Representative, Intellectual Property Organization (IPO)||Member|
|17||Representative, IUCN – The World Conservation Union Pakistan||Member|
|18||Expert, Sustainable Development Policy Institute (SDPI), Islamabad||Member|
|19||Expert Action Aid Pakistan||Member|
|20||Representative, Ministry of Textile Industries, IslamabadCo-opt Member||Member|
|21||Representative, Federal Seed Certification & Registration Department (FSC&RD), IslamabadCo-opt Member||Member|
|22||Director, Pakistan Environmental Protection Agency||Member/Secretary|
(2) The Direcctor, Pakistan Environmental Protection Agency shall act as Secretary of the Technical Advisory Committee.
(3) The committee may co-opt any technical representative from any province.
3. Functions of Technical Advisory Committee.– The following are the functions of advisory Committee.-
a) to examine applications and recommend to National Biosafety Committee on permitting or otherwise laboratory work, field work or release of living modified organism, substances, cells, and products thereof;
b) to review and control of safety measures adopted while handling large Scale use of genetically engineered organisms/classified organisms in research, developmental and industrial production activities;
c) to review research methodologies in genetic engineering and recombinant work at the international level and assess the associated risks to guide re institutions;
d) to monitoring release of engineered organisms/products into environment, oversee field applications and experimental field trials;
e) to provide information/data inputs to National Biosafety Committee upon surveillance of approved projects under industrial production, and in case of environmental releases with respect to safety risks and accidents; and
f) to supervise directly or through any person authorized in this behalf the implementation of the terms and conditions laid down in connection with the approvals accorded by the National Biosafety Committee.
4. Institutional Biosafety Committees.- (1) Institutional Biosafety Committee consists of the following members :
|a) Head of the institution||Chairperson|
|b) Subject expert (s)||Members|
|c) Social Scientist/economist (for social impact)||Member|
|f) Representative of civil society||Member|
|f) Biosafety Officer||Member/Secretary|
5. Functions of Institutional Biosafety Committee._ (I) The Committee shall perform the functions:
a) to assist in the activities of National Biosafety Committee and Technical Advisor Committee;
b) to assist researchers in undertaking risk assessment, organizing training programs and harmonizing experimental conditions with Biosafety guidelines;
c) to determine additional safeguards and draft supplementary operating instructions for won at the institution, in line with and addressing the specific risks and concerns uncovered;
d) to evaluate the qualifications of researchers involved in biotechnological projects and assess whether each retains a thorough understanding of good microbiological practices necessary for the supervision of students, assistants and junior personnel;
e) to monitor all regulated work under progress within the institution and counsel the proponents on issues of Biosafety and on compliance with Biosafety guidelines on a regular basis, or as requested;
f) to serve, where appropriate as a gateway for the flow of information, ideas and opinion between the National Biosafety Committee and the research teams;
g) to maintain and update a directory of all personnel engaged in activities at every Biosafety level, and instruct new personnel on the correct laboratory and? or field practices emergency procedures and equipment operation at the relevant level;
h) to ensure health of laboratory and field personnel as may deem necessary from medical records;
i) to liaise with National Biosafety Committee and Technical Advisory Committee on import export, manufacture, process, use or sale of any genetically modified organisms/substance. or cells and products thereof for the purpose of research;
j) to withhold funds and or use administrative authority to immediately refrain programs if Biosafety guidelines are violated;
k) to prepare and implement the institutional emergency and response plan according to the details provided in the manuals/guidelines prepared by National Biosafety Committee;
l) to assess all projects referred to it, and on the basis of the information provided and the risks forecast determine under which category of work the proposals fall and whether to endorse the work proposed;
m) to maintain records of approved project proposals for laboratory genetic manipulation work (including notification for project exemption) and the assessments;
n) to forward summaries of all project proposals submitted for IBC notification, and the assessments to the Technical Advisory Committee for records and information or for review and recommendation in the case of proposals for Risk Category 2 and 3 work;
o) to undertake risk assessment, in cooperation with the research teams as necessary, to determine the appropriate containment and Biosafety conditions, operating procedures and emergency safeguards for Risk Category 2 and 3 genetic manipulation work, and for the housing, storage or movement of regulated material and also the waste;
p) to prepare, in conjunction with the research teams, specific contingency plans after undertaking risk assessments and reviewing project proposals;
q) to with particular emphasis on Risk Category 3 work, enforce all recommendations, and ensure that the conditions of National Biosafety Committee have been acknowledged and promptly addressed;
r) to inspect and certify, before use in genetic manipulation work. C 1 level laboratories, conventional animal houses, PH 1 plant glass houses, and quarantine and medical facilitates for infected animals; and
s) to monitor and assay the containment features of and the working conditions within all laboratories, plant glass houses and animal houses supporting the institution’s work, to ensure that the various facilities are maintained at the standards and requirements delineated in Appendices 4 through 11 of Biosafety guidelines.